Cleared Traditional

SPLATTER SHIELD (K915676) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915676 · Chathamborough Research Group, Inc. · General Hospital
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Sep 1992
Decision
267d
Days
Class 2
Risk

K915676 is an FDA 510(k) clearance for the SPLATTER SHIELD. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Chathamborough Research Group, Inc. (Pittsboro, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 267 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Chathamborough Research Group, Inc. devices

Submission Details

510(k) Number K915676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date September 11, 1992
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 228
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K915676.
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K921833 · Ethicon, Inc. · Sep 1992
IRRIGATING SYRINGE
K912437 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
B-D INTERLINK SYRINGE CANNULA
K920422 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992